What about Pradaxa (Dabigatran)?

From the Guidelines

Pradaxa (Dabigatran) is a recommended alternative to warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

Key Points

• Dabigatran has been shown to be at least non-inferior to warfarin in preventing stroke and systemic embolism, with a lower risk of intracranial hemorrhage 1.
• The recommended dose of dabigatran is 150 mg twice daily for patients with a creatinine clearance >30 mL/min, and 75 mg twice daily for patients with severe renal insufficiency (creatinine clearance 15-30 mL/min) 1.
• Dabigatran has been associated with a lower risk of major bleeding compared to warfarin, particularly at the 110 mg twice daily dose 1.
• However, dabigatran has also been linked to an increased risk of myocardial infarction, although this finding is not statistically significant 1.

Clinical Considerations

• The selection of dabigatran as an antithrombotic agent should be individualized based on risk factors, cost, tolerability, patient preference, and other clinical characteristics 1.
• Patients with a history of bleeding or at high risk of bleeding may benefit from closer monitoring and consideration of alternative anticoagulants 1.
• The transition from warfarin to dabigatran should be managed carefully to minimize the risk of thromboembolism or bleeding 1.
• It is essential to note that there is no specific antidote for dabigatran, and supportive therapy for severe hemorrhage may include transfusions of fresh frozen plasma, packed red blood cells, or surgical intervention if appropriate 1.

From the FDA Drug Label

1 INDICATIONS AND USAGE

1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

1. 2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
2. 3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated.

Main Indications of Pradaxa (Dabigatran):

• Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation
• Treatment of deep venous thrombosis and pulmonary embolism
• Reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism 2

From the Research

Overview of Pradaxa (Dabigatran)

• Dabigatran etexilate, marketed as Pradaxa, is a direct thrombin inhibitor used for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 3, 4, 5.
• It has been shown to be noninferior to warfarin in preventing stroke and systemic embolism, with the 150mg twice-daily dosage being significantly more effective than warfarin 3, 4, 5.

Efficacy and Safety

• Dabigatran etexilate has been associated with lower rates of haemorrhagic stroke, intracranial bleeding, and life-threatening major bleeding compared to warfarin 4, 5.
• The incidence of major bleeding was generally similar to warfarin, but lower with the 110mg twice-daily dosage of dabigatran etexilate 3, 4.
• Dabigatran etexilate is associated with a higher rate of dyspepsia and gastrointestinal bleeding compared to warfarin 3, 4.

Management of Bleeding Complications

• There is no therapeutic agent accepted to reliably reverse the hemorrhagic complications of dabigatran, and management should start with local control of bleeding and transfusion of packed red blood cells if needed 6.
• Transfusion of fresh frozen plasma would not be expected to help control bleeding, and limited data exist for the use of factor VIIa and prothrombin complex concentrates 6.

Cost-Effectiveness

• Cost-utility analyses have shown that dabigatran etexilate 150mg twice daily is cost-effective compared to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation 3.
• The cost-effectiveness of dabigatran etexilate 110mg twice daily is less clear, with some studies suggesting it may not be cost-effective compared to warfarin 3.